Quality Control Microbiology And Compliance Supervisor

COMBIPHAR; Danauindah; Sur place; IDR 180 000 000 - 300 000 000; Plein temps

Résumé du poste

Combiphar hires a Quality Control Microbiology and Compliance Supervisor to lead QC microbiology activities and ensure regulatory compliance at our North Cikarang facility. The role includes planning, executing, and reviewing microbiological testing for materials, in-process samples, and finished products, while guiding investigations into deviations and coordinating audits.

You will mentor staff, organize QC/compliance training, and collaborate with Production, QA, and R&D to safeguard product

Qualifications

• Bachelor’s degree or higher in Microbiology, Pharmacy, Biotechnology, or related field.
• Experience in pharmaceutical QC microbiology and regulatory compliance.
• Strong supervisory and training skills with people management experience.
• Proven ability to lead audits and investigations into deviations.

Responsabilités

• Oversee microbiology QC testing for raw materials, in-process samples, finished products and utilities.
• Ensure compliance with internal quality standards and external regulatory requirements.
• Lead investigations into deviations, out-of-spec results and non-conformances.
• Coordinate internal audits, support regulatory inspections and drive CAPA initiatives.
• Supervise and mentor team members; train staff on QC and compliance procedures.

Connaissances

Supervisory skills

Regulatory compliance

GMP knowledge

Analytical skills

Training and mentoring

Auditing

Communication

Attention to detail

Formation

Bachelor’s degree or higher in Microbiology, Pharmacy, Biotechnology, or related

Description du poste

Company Description

Combiphar, founded in 1971, is a growing consumer healthcare company offering more than 200 quality and affordable prescription and over-the-counter products. Its portfolio includes well-known brands such as OBH Combi cough syrup, Insto eye-care solution, JointFit gel for joint relief, CombiKid vitamin supplements, Privé feminine hygiene wash, and Hezandra hepatoprotector supplements. The manufacturing plant in Padalarang, West Java, is equipped with advanced production technology and holds Therapeutic Goods Administration (TGA) certification, enabling export of selected products to Australia. Combiphar operates its own Research & Development facility focused on optimizing prescription drug quality, including bioavailability, bioequivalence, and nanotechnology. The company has been recognized as one of "Indonesia's Most Reputable Healthcare Brands 2015," highlighting strong brand equity, customer loyalty, and customer experience.

Role Description

The Quality Control Microbiology and Compliance Supervisor is a full-time, on-site role based in North Cikarang. This role oversees microbiology quality control activities, including planning, executing, and reviewing routine and non-routine microbiological testing for raw materials, in-process samples, finished products, and utilities. The supervisor ensures strict adherence to internal quality standards and external regulatory requirements, manages documentation, and leads investigations into deviations, out-of-specification results, and non-conformances. The role coordinates and conducts internal audits, supports regulatory inspections, and drives continuous improvement initiatives within QC microbiology and compliance processes. Day-to-day responsibilities also include supervising and mentoring team members, organizing training on QC and compliance procedures, and collaborating with Production, Quality Assurance, and R&D to maintain product safety and quality.

Qualifications

• Strong Supervisory Skills, including team leadership, workload planning, performance monitoring, and mentoring.


• Demonstrated expertise in Regulatory Compliance, GMP, and relevant local and international pharmaceutical and microbiology standards.


• Advanced Analytical Skills for interpreting microbiological data, identifying trends, and supporting root cause analysis and CAPA activities.


• Experience in Training team members on QC microbiology methods, compliance procedures, and documentation practices.


• Proficiency in Auditing, including planning and conducting internal audits and supporting external inspections.


• Bachelor’s degree or higher in Microbiology, Pharmacy, Biotechnology, or a related scientific discipline.


• Hands-on experience in pharmaceutical QC microbiology (e.g., environmental monitoring, sterility testing, bioburden, endotoxin, and water system testing).


• Strong communication skills and ability to work collaboratively across cross-functional teams.


• Attention to detail, high level of integrity, and commitment to quality and